CRYoablation for Small Tumors As Local Treatment - SIX Trial

Recruiting now · Phase 3

Conditions studied: Breast Cancer, Breast Neoplasm

In brief

To demonstrate the non-inferiority of cryoablation compared to breast surgery for the local treatment of early-stage breast cancer and to conduct a cost-minimization analysis comparing direct costs between treatments.

Key facts

Study ID

NCT06839001

Run by

Hospital do Coracao

People needed

750

Starts

2025-03-01

Expected to finish

2030-03-01

Last updated by the study team

2025-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unifocal primary invasive breast carcinoma
• Tumor size ≤ 2.0 cm (T1)
• Complete pathological report (including results for ER, PR, HER2, Ki-67, and FISH report for the ERBB2 gene, if necessary)
• Lesion visible on ultrasound
• Surgical treatment would be the first option, regardless of immunohistochemistry results

You may not qualify if…

• Multifocal or multicentric invasive breast carcinoma
• Ductal carcinoma in situ
• Breast cancer with skin involvement
• Clinically positive axilla (N1, N2 or N3)
• Distance from lesion and skin less than 5 mm
• Prior neoadjuvant systemic therapy for breast cancer
• Distant metastasis

Where it is running

• Research Institute - Hospital do Coracao — São Paulo, São Paulo, Brazil (enrolling)
• Research Institute - Hospital do Coracao — São Paulo, São Paulo, Brazil

Full record on ClinicalTrials.gov

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